SPL R4

SPL Release 4 (R4)

[Nov-11 2008]

Common Errors [as found during the eList Pilot Program] for R4 files

• Naming of SPL File. The file must be named in the format <root id>.xml
• Hyphens in the DUNS number. The DUNS number must be presented as a nine-digit number string.
• Incorrect Country Code(s). Consult the ISO 3166-1 Alpha-3 Country Code list [available on the FDA SPL Resources Page]
• Incorrect Telephone Number Format. The telephone number for US listings must be presented in the following format: 1-###-###-####

Implementation Guide for ER and DL

[15-Oct-2008] Stylesheet Release 4.0.3: Release notes

The following changes/corrections were made to the Web view:

1. Correct rendition of numbers for an ordered list coded in a table
2. Correct rendition of FEI number for the Establishment Registration SPL
3. Change text of the Patient Counseling Statement boilerplate
4. Add rendition of the Adverse Reaction Statement boilerplate for vaccines for SPL with Highlights Release 3

The following changes/corrections were implemented for the Print view:

1. Add rendition of the value of the <title> element after the SPL Header for SPL without Highlights
2. Add rendition of 10 dotted lines separating the SPL header and <title> element for SPL without Highlights
3. Remove the Adverse Reaction Statements boilerplate for SPL with Highlights Release 4
4. Change text of the Patient Counseling Statement boilerplate
5. Add rendition of the Adverse Reaction Statement boilerplate for vaccines for SPL with Highlights Release 3

Overview of Release 4 process and its Data Elements
{Sept 2008 - provided by Ed Tripp}